When to Submit Prior Notice to FDA

All shipments entering the U.S. containing food, beverages, and dietary supplements are required to submit prior notice to the U.S. Food and Drug Administration (FDA). Prior notice may be submitted by anyone with knowledge of the shipment, including shippers, importers, U.S. Agents, and Customs brokers. Because the FDA uses prior notice submissions to best decide where their inspectors need to be, there are timelines in place for when prior notice must be submitted. Prior notice submitted through FDA’s Prior Notice System Interface (PNSI) may be submitted no more than 15 calendar days before the shipment is due to arrive. Prior notice submitted using the Automated Broker Interface/ Automated Commercial System (ABI/ACS) may be submitted no more than 30 calendar days before the shipment is due to arrive. For either submission method, prior notice must be submitted and confirmed by FDA no less than:

2 hours prior to arrival for shipments arriving by road

4 hours prior to arrival for shipments arriving by rail

4 hours prior to arrival for shipments arriving by air

8 hours prior to arrival for shipments arriving by water

For shipments arriving by international mail or express couriers, the prior notice should be submitted before the package is shipped. Failure to submit prior notice or filing late or inaccurate prior notice to FDA may result in your product being refused entry to the United States.

Registrar Corp can offer guidance to ensure your prior notice is properly filed. For help with prior notice or any other FDA regulations contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations